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Associate Director/Director

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Associate Director/Director, Global Medical Information Company: Agios Pharmaceuticals Inc

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Associate Director/Director, Global Medical Information LocationAgios Pharmaceuticals HQ Job Code 1263 # of openings 1

Associate Director/Director, Global Medical Information, MedicalAffairs

Agios (agios.com) is a biopharmaceutical company committed toapplying our scientific leadership in cellular metabolism totransform the lives of patients with cancer and rare geneticdiseases. We are growing rapidly with an active research anddiscovery pipeline across both therapeutic areas. Agios has twoapproved oncology precision medicines and multiple first-in-classinvestigational therapies in clinical and/or preclinicaldevelopment.

Agios Pharmaceuticals is searching for an AssociateDirector/Director to join our growing Global Medical Affairs team.The Associate Director/Director, Global Medical Information willreport to the Senior Director of Scientific Communications,Publications, and Medical Information and will be responsible forsupporting all Agios pipeline or marketed products and leading themanagement of medical information and related activities.Responsibilities include but are not limited to: writing standardresponse documents, answering escalated medical informationqueries, oversee the activities of the medical information callcenter, review content as a member of the Agios Review Committee,participate in regulatory inspections and internal audits. In thiscentral role, the Associate Director/Director will engage withmultiple internal stakeholders such as Medical Affairs, RegulatoryAffairs, Commercial, Market Access, Clinical Operations, QualityAssurance, Medical Safety and Risk Management, Compliance andLegal.

Key Responsibilities

Manage the Medical Information Call Center and provide vendoroversight

Provide ongoing training to the call center and other groups asneeded (e.g. MSLs etc) on call- handling, newly launched products,relevant disease states, Prescribing information, important newpublications/data releases

Conduct ongoing QA of call center case handling and providetraining as needed

Prepare reports on a quarterly basis related to frequent topicsof inquiry in IDH program and PKR program; presentfindings/trends/gaps at Medical Team meetings

Participate in regulatory inspections and internal audits

Prepare and plan for new product launches as needed

Collaborate with Medical Science Liaisons, Publication teams,Medical Safety and Risk Management, and Product Quality on aregular basis

Develop and update medical information standard responsesummaries with new publications, congress data, press releases,clinical trial information, etc; also includes FAQs, and clinicaltrial scripts.

Perform literature searches on a case by case basis asneeded

Provide accurate, complete, and timely responses to medicalinformation queries and/or direct call center to the proper sourcefor that information or create customized responses (literaturesearches) for US and ex-US requestors

Develop in-depth knowledge on clinical data associated withclinical trials, publications, and studies in Oncology, Hematology,and Rare Genetic Diseases related to Agios programs

Remain abreast of current FDA Guidelines as they relate toMedical Information

Integral member of the Agios Review Committee (ARC, med legalreg review committee)

Communicate relevant and timely clinical/economic evidence onmarketed products to external customers (managed careorganizations, public/private payers, pharmacy benefit managers,specialty pharmacies etc) as well as providers who seek medicalinformation to assist in overcoming reimbursement barriers

Oversee development of product dossiers for marketed products;partner with HEOR

Collaborate with Medical Information group at Celgene/BMS on anongoing basis for co-developed products

Attend and represent Medical Affairs at Congress booths inOncology and RGD

Participate in cross-functional Congress planning and overseethe materials for the Medical Affairs/Medical Information sectionof the exhibit

Development, review, and update SOPs, guidance and specialprojects as assigned

Advanced degree preferred with 6+ years’ experience in medicalinformation, medical affairs or applicable experience working inpharmaceutical environment with transferrable skill set

Strong project management skills and leadership poise a must tonegotiate and facilitate alignment amongst internalstakeholders

Ability to work with teams and manage vendors to ensureefficient and compliant handling of medical informationservices

Ability to create and oversee a budget

Excellent and effective interpersonal and communicationskills

Must be well organized and able to multi-task in a fast-paceddeadline driven environment

Ability to understand and interpret regulations and guidelinesgoverning publications and medical communications (e.g. FDA, OIG,GPP3, ICJME)

Advanced computer and Internet skills, including knowledge of MSapplications such as Word, PowerPoint, and Excel; PubMed; Referencedatabases

Must be flexible and adaptable to meet the needs of a rapidlygrowing organization

Location: Any

Ability to travel (US and International) approximately 20% oftime

Keywords: Agios Pharmaceuticals Inc, Cambridge , Associate Director/Director, Global Medical Information, Other , Cambridge, Massachusetts

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